Blood extracellular vesicles as markers of lung involvement in LAM and TSC.
Prospective Observational Study of the Role of Extracellular Vesicles (EVs) as Biomarkers of Pulmonary Involvement in Patients With Sporadic Lymphangioleiomyomatosis (S-LAM) and Tuberous Sclerosis Complex-Associated LAM (TSC-LAM)
University of Milan · NCT07304856
We will test whether blood extracellular vesicles can show lung involvement in adults with LAM or tuberous sclerosis complex.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | University of Milan (other) |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT07304856 on ClinicalTrials.gov |
What this trial studies
This observational study will collect clinical and functional data plus blood samples from adult women with definite sporadic LAM or TSC-associated LAM during routine outpatient visits at the Pulmonology Unit of ASST Santi Paolo e Carlo in Milan. Plasma will be separated and extracellular vesicles (EVs) will be isolated by centrifugation and characterized for size, concentration, and molecular cargo including proteins, lipids, and nucleic acids. EV results will be correlated with pulmonary function tests and other clinical measures to look for patterns linked to lung involvement. The protocol uses non-invasive blood sampling and standard laboratory EV analysis methods to identify candidate biomarkers.
Who should consider this trial
Good fit: Adult women (≥18 years) with a confirmed diagnosis of definite sporadic LAM or TSC-associated LAM who are followed at the ASST Santi Paolo e Carlo Pulmonology Unit and can give written informed consent.
Not a fit: People with only probable or possible LAM, patients not followed at the Milan center, men (since enrollment is limited to adult women), or anyone unable or unwilling to give consent are unlikely to receive direct benefit.
Why it matters
Potential benefit: If successful, this could provide a blood test to help detect or monitor lung disease activity in people with LAM or TSC.
How similar studies have performed: Extracellular vesicles have shown promise as biomarkers in cancer and other lung diseases, but applying EV profiling specifically to LAM and TSC is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Female participants aged ≥18 years Confirmed diagnosis of tuberous sclerosis complex (TSC) and/or lymphangioleiomyomatosis (definite diagnosis of TSC-LAM or S-LAM) Follow-up at the Pulmonology Unit of ASST Santi Paolo e Carlo, Milan Ability to provide written informed consent Exclusion Criteria: Diagnosis of "probable" or "possible" LAM Refusal to provide written informed consent
Where this trial is running
Milan, Milano
- Pulmonology Unit ASST Santi Paolo e Carlo, Ospedale San Paolo — Milan, Milano, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphangioleiomyomatosis, Extracellular Vesicles, Generation and Function, LAM, TSC, EVs